Conference about Materials Selection for Radiation Sterilized Medical Products

Overview:  

Review of basic polymer chemistry and changes in polymer characteristics can be anticipated and designed for. Learn how to plan for post radiation resistance and lifetime functionality. All radiation modalities (gamma, e-beam, x-ray) will be reviewed for a basic understanding of the sterilization process and the influences that product design and assembly can have on success.

The following subjects will be covered in detail:

Materials Guidance's - AAMI TIR # 17, ASTM

Sterilization validation and Bioburden

Shelf Life Test Methods - Accelerated Aging design

Product design

The influences of product assembly (molding, automation, etc.)'

Material selection and post irradiation degradation

Regulatory Guidance's - AAMI/ISO 11137, TIR #17

Packaging Design and Materials

Why should you Attend: 

"Do it right the first time", choose the most functional and radiation resistant materials for your medical device instead of going through the post launch cycle of product revisions. Also learn the basis for choosing the optimum sterilization modality based on materials, product design, bioburden, and logistics. Learn how to "think like a molecule" and plan and design around radiation induced changes in materials qualities (color, odor, brittleness). How to avoid the materials that are "APT" to fail. 

Learn how to:

Identify the materials that perform best upon radiation

Keep color and odor out of your irradiated products

Enhance product and packaging designs to take advantage of radiation

Which modality (Gamma, E-beam, X-ray) will perform best for my product

Areas Covered in the Session:

Polymers Chemistry - choosing the best polymer candidate

Gamma, E-beam, X-ray sterilization

Accelerated Aging

Product Validation

Sterilization Validation - Establishing the baseline dose (VDmax)

Who Will Benefit:

Medical product design Management and Engineers

Sterilization Experts

Quality Management and Engineers

Regulatory Affairs

Project Managers

Purchasing and Supply Chain Managers

Staff evaluating risk, safety, and effectiveness

R&D Staff - engineering and lab personnel

Process Engineers

Packaging Engineers

Materials Engineers

Manufacturing Engineers

Speaker Profile:

Karl Leinsing has experience with design and project management since 1988 and has been in the Medical Product Device Design and Development industry since 1992. His areas of expertise include full life cycle product development, product conception, polymer selection, thorough computer-aided product design, dynamic mechanical analysis and root cause analysis, molding and manufacturing, project organization, technical presentations and leadership, and cross-functional teamwork. Karl currently holds 19 patents (several patents pending), 5 design awards, was listed as one of "100 notable people in the Medical Device Industry" by Medical Device and Diagnostic Industry (MDDI), and was inducted into the Product Design & Development Engineer Hall of Fame. 

Contact Detail:

Compliance4All DBA NetZealous,

Phone: +1-800-447-9407

Email: support@compliance4All.com

http://www.compliance4all.com/

Event Link : http://bit.ly/29nErWP

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